¥ 15,000,000 ~ ¥ 17,000,000
Exclusive search for a well established medical device company with exciting product pipeline.
Title : RA Manager or Senior Manager
Location : Tokyo, Japan
Reporting : Global RA Head
- Overall leadership to ensure the smooth and swift product registration in the Japan market
- Manage the efficient and effective preparation all necessary documentations by working closely with global R&D teams.
- Manage the effective communication of RA team in the US and EU
- Update, educate, coach or guide the R&D and other functional teams on local regulatory requirements and ensure necessary test and/or assessment of the new products to be completed in time.
- Ensure the discipline among the employees around the PMDA regulatory requirement.
- Line management of the team of 2-4 professionals.
Required Experience and Capabilities
- 5+ years of experience in Regulatory Affairs experience in medical industry
- 2+ years of people management experience.
- Result oriented work attitude – not just managing the processes.
- Resilience to changing environment and challenges
- Business level Japanese and English.